Lung Cancer Clinical Trial
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
Summary
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).
Full Description
The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.
Eligibility Criteria
Inclusion Criteria:
Confirmation of cancer by biopsy (tissue sample)
Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate renal, liver and bone marrow function.
Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Institutional Review Board (IRB) approved, signed and dated informed consent form
Exclusion Criteria:
Prior treatment with study medications
Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept
Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
Severe cardiovascular disease or event
Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
Deep vein thrombosis, pulmonary embolism, or other clotting event
Episode(s)of moderate to severe, continuous bleeding
Breast-feeding or pregnancy
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There are 15 Locations for this study
Tucson Arizona, 85715, United States
Little Rock Arkansas, 72205, United States
Stanford California, 94305, United States
Boynton Beach Florida, 33435, United States
Hines Illinois, 60141, United States
Hazard Kentucky, 41701, United States
Baltimore Maryland, 21231, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
Charlotte North Carolina, 28204, United States
Erie Pennsylvania, 16505, United States
Wheeling West Virginia, 26003, United States
Toronto Ontario, M5G 2, Canada
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